Easter Seals Jobs

Working Location: MINNESOTA, BROOKLYN PARK

Workplace Flexibility: Hybrid

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. _ _

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus (https://www.olympusamerica.com/careers) .

**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

Job Description

This position is responsible for providing Biological Safety support and expertise to the Olympus Surgical Technologies America group and ensuring that the coordination of biocompatibility related Operational activities are in compliance with internal and external requirements and regulations. The Biological Safety Coordinator will assist with medical device evaluations for safety per the ISO 10993 series and will execute testing and reporting for new product development and existing product.

Job Duties

• Supports the evaluation of medical devices for safety per the ISO 10993 series.

• Manage outsourced contract research (GLP- and non-GLP) performed by external laboratories.

• Coordinate biocompatibility testing between internal stakeholders and external laboratories for new and existing products.

• Determine sample requirements for biocompatibility testing per ISO 10993 guidelines and laboratory testing specifications.

• Develop sample preparation instructions for biocompatibility testing.

• Review toxicological and biocompatibility results and document in reports.

• Collaborate with cross functional teams to evaluate manufacturing, material, and product changes for their impact on biological safety.

• Assist with root cause investigation for issues associated with biocompatibility testing.

• Liaison support of external laboratories for the companies’ biocompatibility and toxicological aspects of regulatory submissions.

• Train biological safety team members on the use of internal electronic management systems and documentation practices.

Job Qualifications

Required:

• Bachelor’s degree in Science/Engineering/Biomedical required. MS or higher degree in biochemistry, toxicology or similar discipline preferred.

• Minimum of 3 years of experience with biocompatibility requirements within an FDA regulated medical device environment.

• Strong Knowledge of ISO 10993 and FDA’s Biological Evaluation Guidance.

• Scientific analytical and writing skills.

• Good communication skills and writing skills.

• Familiarity with pertinent FDA, EUMDR, AAMI, OSHA and ASTM regulations and guidelines.

• Travel: <10% domestic/international.

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

• Competitive salaries, annual bonus and 401(k)* with company match

• Comprehensive medical, dental, vision coverage effective on start date

• 24/7 Employee Assistance Program

• Free live and on-demand Wellbeing Programs

• Generous Paid Vacation and Sick Time

• Paid Parental Leave and Adoption Assistance*

• 12 Paid Holidays

• On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

• Work-life integrated culture that supports an employee centric mindset

• Offers onsite, hybrid and field work environments

• Paid volunteering and charitable donation/match programs

• Diversity Equity & Inclusion Initiatives including Employee Resource Groups

• Dedicated Training Resources and Learning & Development Programs

• Paid Educational Assistance

*US Only

**Center Valley, PA and Westborough, MA

Are you ready to be a part of our team?

Learn more about our benefit and incentives (https://www.olympusamerica.com/careers/benefits-perks) .

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .

Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Applicants with Disabilities:

As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Posting Notes: || United States (US) || Minnesota (US-MN) || Brooklyn Park || Quality & Regulatory Affairs (QA/RA)